Medical device management system

ABSTRACT

The present disclosure provides systems and methods for calibrating medical devices and processing physiological measurements using a medical device management system. As an example, the medical device can be a handheld glucometer configured for invasive testing and non-invasive testing of physiological parameters of a patient.

RELATED APPLICATIONS INCORPORATION BY REFERENCE TO ANY PRIORITYAPPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are incorporated by reference under 37 CFR 1.57 and made apart of this specification.

BACKGROUND

Medical device manufacturers are continually increasing the processingcapabilities of physiological monitors that process signals based uponthe attenuation of light by a tissue site. In general, suchphysiological monitoring systems include one or more optical sensorsthat irradiate a tissue site and one or more photodetectors that detectthe optical radiation after attenuation by the tissue site. The sensorcommunicates the detected signal to a physiological monitor, whichremoves noise and preprocesses the signal. Advanced signal processorsthen perform time domain and/or frequency domain processing to determineblood constituents and other physiological parameters.

Manufacturers have advanced basic pulse oximeters from devices thatdetermine measurements for blood oxygen saturation (SpO2), pulse rate(PR) and plethysmographic information to read-through-motion oximetersand to cooximeters that determine measurements of many constituents ofcirculating blood. For example, Masimo Corporation of Irvine Calif.(“Masimo”) manufactures pulse oximetry systems including Masimo SET® lownoise optical sensors and read through motion pulse oximetry monitorsfor measuring SpO2, PR and perfusion index (PI). Masimo optical sensorsinclude any of Masimo LNOp®, LNCS®, SofTouch™ and Blue™ adhesive orreusable sensors. Masimo pulse oximetry monitors include any of MasimoRad-8®, Rad-5®, Rad®-5v or SatShare® monitors. Such advanced pulseoximeters and low noise sensors have gained rapid acceptance in a widevariety of medical applications, including surgical wards, intensivecare and neonatal units, general wards, home care, physical training,and virtually all types of monitoring scenarios.

Many innovations improving the measurement of blood constituents aredescribed in at least U.S. Pat. Nos. 6,770,028; 6,658,276; 6,157,850;6,002,952; 5,769,785 and 5,758,644, which are assigned to Masimo and areincorporated by reference herein. Corresponding low noise opticalsensors are disclosed in at least U.S. Pat. Nos. 6,985,764; 6,088,607;5,782,757 and 5,638,818, assigned to Masimo and hereby incorporated intheir entirety by reference herein.

Advanced blood parameter measurement systems include Masimo Rainbow®SET, which provides measurements in addition to SpO2, such as totalhemoglobin (SpHb™), oxygen content (SpOC™), methemoglobin (SpMet®),carboxyhemoglobin (SpCO®) and PVI®. Advanced blood parameter sensorsinclude Masimo Rainbow® adhesive, ReSposable™ and reusable sensors.Advanced blood parameter monitors include Masimo Radical-7™, Rad87™ andRad57™ monitors, all available from Masimo. Advanced parametermeasurement systems mayaiso include acoustic monitoring such as acousticrespiration rate (RRa™) using a Rainbow Acoustic Sensor™ and Rad87™monitor, available from Masimo. Such advanced pulse oximeters, low noisesensors and advanced parameter systems have gained rapid acceptance in awide variety of medical applications, including surgical wards,intensive care and neonatal units, general wards, home care, physicaltraining, and virtually all types of monitoring scenarios. An advancedparameter measurement system that includes acoustic monitoring isdescribed in U.S. Pat. Pub. No. 2010/0274099, filed Dec. 21, 2009,titled Acoustic Sensor Assembly, assigned to Masimo and incorporated inits entirety by reference herein.

Innovations relating to other advanced blood parameter measurementsystems are described in at least U.S. Pat. 7,647,083, filed Mar. 1,2006, titled Multiple Wavelength Sensor Equalization; U.S. Pat. No.7,729,733, filed Mar. 1, 2006, titled Configurable PhysiologicalMeasurement System; U.S. Pat. Pub. No. 2006/0211925, filed Mar. 1, 2006,titled Physiological Parameter Confidence Measure and U.S. Pat. Pub. No.2006/0238358, filed Mar. 1, 2006, titled Noninvasive Multi-ParameterPatient Monitor, all assigned to Cercacor Laboratories, Inc., Irvine,Calif. (Cercacor) and all incorporated in their entirety by referenceherein.

SUMMARY

In some embodiments the present disclosure provides a method forprocessing physiological measurements. The method including receiving,by a medical device management system, physiological measurement datafrom a portable medical device. The physiological measurement dataincludes identification information associated with a user of theportable medical device. The method also includes identifying a useraccount of the medical device management system based on identificationdata, processing the physiological measurement data to determine atleast one physiological parameter associated with the physiologicalmeasurement data, transmitting the determined at least one physiologicalparameter to the portable medical device for display, and storing thephysiological measurement data and the determined at least onephysiological parameter in the identified user account.

In some embodiments the present disclosure provides a method forcalibrating a portable medical device. The method includes receiving arequest for calibration from a portable medical device. The requestincludes identification information associated with the medical device.The method further includes identifying an account associated with themedical device based on the identification information, determining thatthe device needs calibration based on the information stored in theaccount, sending a signal to the medical device to initiate acalibration mode on the medical device, receiving calibration data fromthe medical device, processing the calibration data to determine acalibration of the device, transmitting an updated calibration tomedical device, and storing the updated calibration in the accountassociated with the medical device.

In some embodiments the present disclosure provides a medical devicemanagement system including a data store and a computing device. Thedata store can be configured to store user account informationassociated with a plurality of user accounts. The computing device is incommunication with the data store and can be configured to receive ameasurement request from a portable medical device. The measurementrequest can include physiological measurement data. The computing devicecan be further configured to identify a user account of the plurality ofuser accounts associated with the measurement request, process thephysiological measurement data to determine at least one physiologicalparameter associated with the physiological measurement data, transmitthe determined at least one physiological parameter to the portablemedical device for display and storing the physiological measurementdata and the determined at least one physiological parameter in theidentified user account.

For purposes of summarizing the invention, certain aspects, advantagesand novel features of the invention have been described herein. Ofcourse, it is to be understood that not necessarily all such aspects,advantages or features will be embodied in any particular embodiment ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages will becomemore readily appreciated as the same become better understood byreference to the following detailed description, when taken inconjunction with the accompanying drawings:

FIG. 1 illustrates a block diagram depicting an illustrative embodimentof an operating environment for a medical device management system.

FIG. 2 illustrates a perspective view of an embodiment of a handheldglucometer.

FIG. 3 illustrates an end view of the embodiment of the handheldglucometer from FIG. 2.

FIG. 4 illustrates an opposite end view of the embodiment of thehandheld glucometer from FIG. 2.

FIG. 5 illustrates an exploded view of the embodiment of the handheldglucometer from FIG. 2.

FIG. 6 illustrates a method of updating the calibration of a medicaldevice using a medical device management system.

DETAILED DESCRIPTION

FIG. 1 illustrates an embodiment of an operating environment 100 for amedical device management system 110. The operating environment includesa medical device management system 110 configured to communicate with aplurality of medical devices 130 and 140 over a network 102. The medicaldevice management system 110 can also be referred to as a network-basedor cloud-based management system.

Those skilled in the art will appreciate that the communication network102 may be any wired network, wireless network or combination thereof.In addition, the communication network 102 may be a personal areanetwork, local area network, wide area network, cable network, satellitenetwork, cellular telephone network, or combination thereof. Protocolsand components for communicating via the Internet or any of the otheraforementioned types of communication networks are well known to thoseskilled in the art of computer communications and thus, need not bedescribed in more detail herein.

In this embodiment, the medical device management system 110 includes anaccount management module 112, an algorithm processing module 114, aninterface module 116, and a data collection module 118. The medicaldevice management system 110 is in communication with a data store 120.The data store 120 can store data received from the medical devices 130and 140.

In general, the word module, as used herein, refers to logic embodied inhardware or firmware, or to a collection of software instructions storedon a non-transitory, tangible computer-readable medium, possibly havingentry and exit points, written in a programming language, such as, forexample, C, C++, C#, or Java. A software module may be compiled andlinked into an executable program, installed in a dynamic link library,or may be written in an interpreted programming language such as, forexample, BASIC, Perl, or Python. It will be appreciated that softwaremodules may be callable from other modules or from themselves, and/ormay be invoked in response to detected events or interrupts. Softwaremodules may be stored in any type of computer-readable medium, such as amemory device (e.g., random access, flash memory, and the like), anoptical medium (e.g., a CD, DVD, BluRay, and the like), firmware (e.g.,an EPROM), or any other storage medium. The software modules may beconfigured for execution by one or more CPUs in order to cause themedical device management system 110 to perform particular operations.

It will be further appreciated that hardware modules may be comprised ofconnected logic units, such as gates and flip-flops, and/or may becomprised of programmable units, such as programmable gate arrays orprocessors. The modules described herein are preferably implemented assoftware modules, but may be represented in hardware or firmware.Generally, the modules described herein refer to logical modules thatmay be combined with other modules or divided into sub-modules despitetheir physical organization or storage.

The medical devices 130 and 140 can be configured to measure and recordphysiological signals from a user. The physiological signals including,but not limited to, blood pressure (diastolic), blood pressure(systolic), PR, glucose, total hemoglobin (SpHb), SpO2, PI, venousoxygen saturation (SpVO2), pleth variability index (PVI), SpCHOL, SpBUN,SpHDL, and/or other physiological parameters.

The medical devices 130 and 140 can have an associated sensor, such asan optical sensor, to monitor physiological parameters. One example ofan optical sensor is described in detail with respect to U.S. patentapplication Ser. No. 13/646,659 titled Noninvasive Blood AnalysisSystem, filed Oct. 5, 2012, assigned to Cercacor and incorporated in itsentirety by reference herein. A blood glucose monitor is described indetail with respect to U.S. patent application Ser. No. 13/308,461titled Handheld Processing Device Including Medical Applications forMinimally and Noninvasive Glucose Measurements, filed Nov. 30, 2011,assigned to Cercacor and incorporated in its entirety by referenceherein. A blood glucose monitor and sensor are described in detail withrespect to U.S. patent application Ser. No. 13/473,477 titled PersonalHealth Device, filed May 16, 2012, assigned to Cercacor and incorporatedin its entirety by reference herein. A blood glucose calibration systemis described in detail with respect to U.S. patent application Ser. No.13/726,539 titled Blood Glucose Calibration System, filed Dec. 24, 2012,assigned to Cercacor and incorporated in its entirety by referenceherein.

The medical devices 130 and 140 can communicate with the medical devicemanagement system 110 via the network 102. In some embodiments, amedical device can be a network-capable device, such as medical device130. The medical device 130 can be configured to communicate directlywith the medical device management system 110. The medical device 130can have an interface module 160 configured to manage communicationbetween the medical device management system 110 and the medical device130. The interface module 160 can be specific to the medical device 130and each type of medical device can have a different interface module160. Some medical devices, such as medical device 140, communicate withthe medical device management system 110 via a host computing device150.

The computing device 150 can correspond to a wide variety of devices orcomponents that are capable of initiating, receiving or facilitatingcommunications over the communication network 102 including, but notlimited to, personal computing devices, hand held computing devices,integrated components for inclusion in computing devices, smart phones,modems, personal digital assistants, laptop computers, media devices,and the like.

The computing device 150 can have an interface module 160 that can beconfigured to interface with the medical device management system 110.The interface module 160 can be configured to provide a user with accessto the medical device management system 110. The interface module 160can be an application that operates on the computing device 150. Theapplication can be configured to recognize the medical device 140 whenthe device is in communication with the computing device 150. Theinterface module 160 can be used when the medical device 140 is notcapable of communicating directly with the medical device managementsystem 110 over the network. The medical device 140 can communicate withthe interface module 160 via a physical connection to a computing device150 (e.g., a USB connection) or using wireless communication protocols(e.g., WiFi, Bluetooth, etc.).

The interface module 160 can be configured to communicate with themedical device management system and provide and receive informationfrom the medical device. The information provided by the medical deviceto the medical device management system 110 can include information suchas device serial number, calibration information, synchronizationinformation, biometric data, and other types of data or information,.For simplicity, reference will generally be made to the medical device130 when describing interactions between a medical device and themedical device management system 110. The functionality described withrelation to medical device 130 can be implemented on medical device 140,either directly or through another computing device. Depending on thespecific type of medical device, none, some or all of the features andfunctionality discussed herein may be implemented locally on the medicaldevice.

The medical device management system 110 can include a user portal and aback end infrastructure. The medical device management system 110 canstore, organize and present medical data collected by the medical deviceto the user. The account management module 112 can manage the useraccounts in the medical device management system 110. The algorithmprocessing module 114 can be configured to utilize algorithms todynamically and quickly determine blood constituent values that wouldnot be calculable locally on a portable medical device. The interfacemodule 116 can be configured to interface with the medical devices 130and 140 via the respective device-side interface modules 160. Theinterface module 116 can also be configured to manage a web-basedinterface. Further, the interface module 116 can be responsible forsynchronization of the medical with the medical device management system110. The interface module 116 can also be responsible for uploading datato the medical device management system 110. The data collection module118 can store, organize and present medical data collected by thedevices to the users and interface with the data store 120.

The medical device management system 110 can utilize an account-basedmanagement system. Each user can set up a user account that can beassociated with one or more medical devices. The user can provideinformation during an account registration process, such as demographicinformation, age, gender, date of birth, height, weight, credit cardinformation, and/or other user information.

Users can interact with the medical device management system 110 toinitialize, configure, synchronize and manage their medical devices. Themedical device management system 110 can perform data processing of themedical data collected from the medical devices. When a user hasregistered their medical device(s) to their user account on the medicaldevice management system 110, the user can have access to medical datacollected by their medical device. Each user can use the medical devicemanagement system 110 as a portal through which they can monitor andmanage their medical data over time. The medical device managementsystem 110 can sort through the user's data and present it in relevantviews (such as monthly trends, yearly trends, after meal trends, etc.).In some embodiments, the user can personalize the medical device, suchas creating a name for the device, selecting the language of the device,privacy settings, alarms, thresholds, and other options. The privacysettings can allow the user to choose whether to share their data withothers. For example, the user can choose not to share the data, or theuser can share the data with others, such as with their family, theirdoctor, and/or everyone.

Prior to use, the interface module 160 communicate with the medicaldevice management system to initialize and configure the medical device130 and synchronize the medical device 130 with a user's personalaccount within the medical device management system 110. Afterconfiguration, the medical device can be registered and synced to theuser's medical device management system account and data collected onmedical device can be synchronized and uploaded to the user's medicaldevice management system account. In some embodiments, a user can accessthe medical device and make configuration settings for the medicaldevice via a web interface by logging in to the medical devicemanagement system. Changes made to the configuration settings in the webinterface can be pushed to the medical device during a synchronizationprocedure. For example, if there is a change detected, the interfacemodule 160 can retrieve the configuration table from medical devicemanagement system 110 and apply the configuration to the connecteddevice. Identification information associated with a user account and/oruser device can be used to associate the physiological measurement datareceived from a device with a user account. The identificationinformation can include information such as a user ID, device ID (e.g.,serial number), user credentials, tokens, or other types of informationthat can be used by the medical device management system. For example,when the medical device management system receives physiological data,the data could include identification information that can be used toidentify the user account and/or device associated with thephysiological measurement data.

In one embodiment of the initialization process, the interface module160 can retrieve identification information or data such as, usercredentials, device ID (e.g., serial number), and/or other requiredand/or relevant information from the device. The information can be sentto the medical device management system 110. The receipt of informationby the medical device management system 110 from the medical device 130can trigger the medical device management system 110 to provide anauthentication token to the medical device 130. The authentication tokencan be provided to the medical device 130 via the interface module 160,which can be stored on the device for authentication and identificationpurposes.

The medical device management system 110 can be configured to allowmultiple users to use the same medical device. One user can bedesignated as the device administrator within the medical devicemanagement system 110. After the medical device is registered andinitialized for use by a device administrator, additional users can beassociated with the medical device. The additional users can use themedical device and have their personal medical data managed on aseparate user account with the medical device management system 110. Insome embodiments, an administrator can grant additional users access bysending an invitation via their medical device management systemaccount. An unregistered user (e.g., guest user) may still be able touse the medical device, however, the medical device management systemmay not store and track the unregistered user's data.

A medical device that has been registered can synchronize the datastored on the medical device with the medical device management system110. The interface module 160 can retrieve the physiological data fromthe medical device and send it to the medical device management system110. The medical device management system can store the physiologicaldata in the data store 120. The stored data can be retrieved and sortedby the user.

Data sent from the medical device to the medical device managementsystem 110 can trigger creation of a file with information associatedwith the physiological data. In one embodiment the file can include, atimestamp, a location of a binary file (raw physiological data), andlocation that an output file should be stored. Online Data Processing

The medical device management system 110 can provide massive computingcapability in the cloud for many users and devices. The increasedcomputing power can be used to run increasingly more complex algorithmsas well as supporting multiple devices simultaneously. The algorithmsrunning on the medical device management system 110 can be updated. Theversion and specifics of the algorithm can also be traceable and therecan be a log of each update.

When the medical device management system 110 receives new physiologicaldata from a medical device, it can store the data in the data store 120.The medical device management system 110 can create a reference file,such as an XML file, referencing the new physiological data and invokingthe algorithm processing module 114. The reference file can provide theinformation necessary to access the physiological information, run therequired algorithm, calculate the results (or return an error code ifunable to generate a result), and then create the desired output file.The output file can include information such as measured parameters,processing time, errors that may have occurred, algorithm version, andtimestamp. The medical device management system can send the resultsback to the device to be displayed for the user. The medical devicemanagement system can save the output results in the database for futureuse.

Since the medical device management system 110 can have a virtuallyunlimited storage capacity, more complex algorithms can be implementedwhich utilize a patient's historical data in order to improve futuremeasurements. For example, a patient-unique calibration may utilizehistorical measurements and calibration points to reach a betteraccuracy. The medical device management system can store and retrievedata and filter results by device ID, User ID, date etc., so that thealgorithm knows which files are relevant for each particular subject andshould be used in generating a calibration.

The medical device 130 can determine whether the medical devicemanagement system 110 is ready to begin processing data. If medicaldevice management system is not ready, the medical device can return anerror after a timeout period. If the medical device management system110 is ready, the system can begin caching resources in preparation fordata processing. The device can begin collecting and streamingphysiological data associated with the user to the medical devicemanagement system 110. The medical device management system 110 canprocess the collected data and determine one or more physiologicalmeasurements based on the physiological data. The medical device can beconfigured to provide the raw data to the medical device managementsystem 110 for processing. The raw data may undergo some processing(e.g., filtering) prior to being transferred to the medical devicemanagement system. In some embodiments, the medical device 130 can beconfigured to determine whether there is a connection to the medicaldevice management system 110 prior to processing the data. For example,if there is no connection, the device may process the physiological datalocally. Whereas, if there is a connect to the medical device managementsystem 110, the device can send the data to the system 110 forprocessing. The system can also calibrate the medical device, which willbe further discussed with relation to FIG. 6. Handheld Glucometer

With reference now to FIGS. 2-5, an illustrative embodiment of ahandheld medical device 200 is illustrated. The handheld medical device200 can also be referred to as a handheld glucometer. The handheldglucometer 200 includes a housing 210, a display 220, a plurality ofcontrol buttons 230, an I/O port 240, a glucose reader 250, and a sensorconnector 260.

The handheld glucometer 200 can be utilized for invasive and/ ornon-invasive blood glucose monitoring or non-invasive partial bloodpanel monitoring by home users in a non-clinical setting or trainedindividuals in a clinical setting. The handheld glucometer 200 canperform one or more of the following physiological measurements:invasive glucose testing, non-invasive blood glucose testing, OxygenSaturation (SpO2), Total Hemoglobin (SpHb), Alkaline Phosphatase(SpALP), Total Cholesterol (SpChol), High-Density Lipoprotein (SpHDL),Total Cholesterol Divided by High Density Lipoprotein (SpChol/SpHDL).

The handheld glucometer 200 can perform invasive blood glucosemeasurements when the user lancets their finger for a capillary bloodsample and places it onto a glucose test strip that is inserted into thehandheld glucometer 200. The invasive blood glucose measurements can beused for at least two functions. First, the invasive measurements can beused by the handheld glucometer 200 during calibration. The handheldglucometer 200 can request that invasive calibration measurements betaken from time to time, such as during the initial use of the device inorder to set a standard of calibration for the patient and thenon-invasive sensor. Second, the user can take invasive measurements totest the accuracy of the non-invasive blood glucose measurements or whenthe user prefers to have an invasive measurement taken. The handheldglucometer 200 can help to reduce the frequency of pain associated withtypical home blood glucose meters that require invasive blood drawsapproximately 4-7 times per day. Advantageously, with the handheldglucometer 200 a user may be able to reduce the number of invasive blooddraws to 1-2 per week if they can be replaced with 4-7 non-invasivemeasurements per day, which can reduce the pain associated with frequentlancing and reduce the likelihood of tissue damage.

The handheld glucometer 200 can be used in conjunction with the medicaldevice management system 110. The handheld glucometer 200 cancommunicate with the medical device management system 110 via acomputing device 150. In some embodiments, the handheld glucometer 200can be physically connected to the computing device 150, such as a USBconnection, or a wireless connection, such as a Bluetooth connection.The computing device can be a mobile computing device such as a smartphone, or another computing device such as a desktop computer. Themedical device management system 110 can allow the user to review trendsand user logged variables that can contribute to highs and lows in theirglucose values. The results can be shared with family, friends, and caregivers.

The display 220 can display text and graphics. In one embodiment, thedisplay 220 can be an OLED display. In one embodiment, the display 220can have a resolution of 128×96 pixels. The display can have a viewingangle that is greater than or equal to about 45 degrees on all axes. Thedisplay 220 can have a user interface. The user interface can beconfigured to show a wireless connectivity state, such as a Bluetoothconnection state. The user interface can be configured to show batterycapacity icon with states of charge remaining and/or charge state. Theuser interface can display a real-time clock that can be accurate towithin 10 minutes per year, which the handheld glucometer 200 can use totime stamp each test. The handheld glucometer 200 can provide the userwith the option to select from available regional time zones. The userinterface can track and display an average on a preconfigured number ofdays and can display a total number of glucose results. In someembodiments, the handheld glucometer 200 can prevent users from omittingnon-invasive or invasive glucose test results.

The handheld glucometer 200 can have various operating states, such asan off mode where the processor is powered off; a low-power operatingmode where the processor power is minimized, the display 220 is off, andwireless connections can be maintained; and a normal operating modewhere the display 220 is on and the processor is fully operating. Thehandheld glucometer 200 can transition from low power mode to normaloperating mode by a user press of a hard button, a user inserting aninvasive strip, or a user attaching a non-invasive sensor.

The handheld glucometer 200 can have various test configurations, suchas on-demand where the handheld glucometer 200 ready for an invasiveglucose test when a user inserts an invasive strip in the device, orready for a non-invasive glucose test when a user connects thenon-invasive sensor. The handheld glucometer 200 can performnon-invasive measurements in less than 180 seconds (e.g., three 60second measurements if/when necessary). The handheld glucometer 200 canperform invasive measurements in less than 10 seconds.

The handheld glucometer 200 can have a plurality of control buttons,including a “Start/Stop” button, “Plus/ Minus” buttons, a “Trend Button”configured to show previous tests, a volume button configured to adjustthe volume, and a wireless connectivity button. The handheld glucometer200 can have a Micro USB connector to facilitate battery charging, datatransfer of measurement data, and software upgrades.

The handheld glucometer 200 can have a glucose reader 250 comprising ashell 252 and a slot 254 for the invasive strip glucose reader. Theglucose strip reader 250 can be on different side of device from sensorconnector 260. The glucose strip reader 250 can facilitate invasivetesting and calibration testing. The slot 254 can be illuminated tofacilitate the insertion of the test strip into the slot by the user.

The handheld glucometer 200 can automatically recognize when a teststrip is inserted into the slot 254. The handheld glucometer 200 caninstruct a user on how to operate the device during a testing procedure.The display 220 can show a percentage complete or seconds remainingcount-down during an invasive glucose measurement. The display 220 candistinguish between invasive glucose values and other measuredparameters.

For non-invasive measurements, the display 220 can show a percentagecomplete or count-down during a measurement. The handheld glucometer 200can have a non-invasive glucose calibration capability that has afrequency that can be automatically controlled by device and/or manuallyrun by a user at any time. The handheld glucometer 200 can have a lockout mechanism to prevent non-invasive glucose tests if the system hasnot been successfully calibrated. The display 220 can distinguishbetween non-invasive glucose values and other measured parameters ondevice.

The handheld glucometer 200 can have a quality control test mode to helpverify that the system is operating within specifications. In thequality control test mode, the handheld glucometer 200 tests themeasurement values associated with control test strips that utilizecontrol solutions. The control test strips have known associated testvalues. The handheld glucometer 200 can also have a non-invasive qualitycontrol method that permits a user or manufacturing personnel to checkthe validity of the non-invasive system with a rainbow parameter sensor.

The handheld glucometer 200 can have a radio interface to communicatevia radio communication, such as Bluetooth 2.0-4.0 and Bluetooth lowenergy (BLE), in order to facilitate data transfer (measurements andphysiological data), connection to a computing device, such as a mobiledevice. The handheld glucometer 200 has non-volatile memory, such as anon-removable MicroSD card, to maintain system software and usermeasurements.

The handheld glucometer 200 can have a rechargeable battery, such as a1600 mAH Li+ battery. The handheld glucometer 220 can perform a minimumof 20 consecutive non-invasive test measurements from full charge. Thehandheld glucometer 200 can perform measurements while charging andcharge at full rate when in low power mode. At full rate, the handheldglucometer 200 can charge the battery in less than 6 hours. The handheldglucometer 200 can operate in a standby mode for a minimum of 18 hoursper full charge.

The sensor interface 260 can connect to a non-invasive sensor such as anoptical sensor, such as one of the sensors described above that beconnected to the medical devices 130 and 140. Some measurement valuesgenerated by a non-invasive sensor can include oxygen saturation (SpO2),pulse rate (PR), perfusion index (PI), total hemoglobin (SpHb), alkalinephosphatase (SpALP), total cholesterol (SpChol) (3406), high-densitylipoprotein (SpHDL), total cholesterol divided by high densitylipoprotein (SpChol/SpHDL), and non-invasive glucose (SpGlu). Otherparameters can be viewable through the host device or a web application.

The handheld glucometer 200 can be user configurable by a host device(e.g., a computing device in communication with the handheld glucometer)or a website to make changes to the user interface. The user candetermine a priority for non-invasive measurement and determine thedisplay characteristics of the measurement values. The user candetermine which measurement value is the default measurement after anon-invasive test is performed. The handheld glucometer 200 can haveuser set parameters for upper and lower limit notification controlsettings. The parameters can be set from the host device or a web-basedinterface with the medical device management system 110. The user canset restrictions on the access and notification of the previous testresults stored in the medical device management system. The handheldglucometer 200 can have measurement alerts that can have a visual and/oran audio alert to notify the user when measurement levels, invasive ornon-invasive, exceed a specified measurement range. The medical devicemanagement system can have a diabetes management system to displayhistorical data and trends.

With reference now to FIG. 6, a calibration routine 600 for a medicaldevice is illustrated. The calibration routine 200 can be performedgenerally by the medical device management system, and morespecifically, by one or more modules of the medical device managementsystem 110, such as the algorithm processing module 114, the interfacemodule 116, and/or the data collection module 118. The calibrationroutine can be for single point calibration, multi-point calibrationand/or other medical device specific calibration techniques.

At block 602, the medical device management system 110 can receive arequest for calibration from the medical device 202. The medical device130 can query the medical device management system 110 to determinewhether calibration is required. The medical device 130 can query themedical device management system 110 each time measurement data iscollected, after a defined number of measurements, after a determinedtime period, or other criteria.

At block 604, the medical device management system 110 can determinecalibration of the medical device is required. The medical devicemanagement system 110 can determine that calibration is required basedon the information contained in the request received from the medicaldevice 130. In some embodiments, the medical device management system110 determines if and when calibration is required based on previouslystored data. In such cases, the medical device management system 110 mayactively initiate calibration of the medical device 130 withoutpreviously receiving a request from the medical device 130. If themedical device management system 110 determines that no calibrationrequired, data acquisition can occur as normal.

If calibration is required, at block 606, the calibration mode can beinitiated on the medical device. The calibration mode can be a separatefunction on the device that handles communication with the medicaldevice management system 110 independently of the data collection. Thecalibration mode on the medical device can be configured to lock themedical device from further use until calibration is completed. Incalibration mode the medical device can send calibration data, such asmeasurement values, error codes, timestamps, device ID, sensor ID, andother information to the medical device management system 110. Thespecific calibration information required by the medical devicemanagement system 110 is dependent on the type of the device, type ofcalibration, and/or other device or system specific information.

In one embodiment for a non-invasive glucose calibration, the device canperform a manual entry calibration and a calibration using a built instrip reader. For manual entry calibration, the user can have the optionof manually entering their glucose value into the medical device. Manualentry gives the flexibility to use a reference device other than theinternal strip reader to help with calibration. For a strip readercalibration, the user can immediately measure their glucose value with abuilt in strip reader based on an invasive test. The device can alsomeasure the glucose value using a non-invasive test and the values canbe sent to the medical device management system 110 to calculate theresults of the calibration.

At block 608, the medical device management system 110 calculates acalibration for the medical device based on the calibration datareceived from the medical device 130. The medical device managementsystem 110 can determine the calibration based on the specificcalibration information stored in the system. For example, a lookuptable may be used to determine the calibration for the device. Moreadvanced algorithms and patient specific calibrations may be used basedon the information provided by the medical device.

The medical device management system 110 can store all of the dataassociated with a specific patient and a specific device, therebyallowing the system to tailor the calibration to the specific patientand the specific device. For example, a patient-unique calibration mayutilize historical measurements and calibration points to reach a betteraccuracy. The medical device management system can store and retrievedata and filter results by device ID, User ID, date etc., so that thealgorithm knows which files are relevant for each particular subject andshould be used in generating the patient unique calibration. Thecalibration information can be stored in the data store 120, so that itcan be referenced at a later time.

After the calculation of the calibration is complete, at block 610, thecalibration can be updated on the medical device. The medical devicemanagement system 110 can provide the updated calibration data to themedical device 130. After updating the calibration, the medical devicecan transition from the calibration mode to measurement mode, which canallow the user to perform measurements as required. The calibrationroutine ends at block 612.

In addition to those processes described above, other processes andcombination of processes will be apparent to those of skill in the artfrom the present disclosure. Those of skill will further appreciate thatthe various illustrative logical blocks, modules, and steps described inconnection with the embodiments disclosed herein may be implemented aselectronic hardware, computer software, or combinations of both. Toclearly illustrate this interchangeability of hardware and software,various illustrative components, blocks, modules, and steps have beendescribed above generally in terms of their functionality. Whether suchfunctionality is implemented as hardware or software depends upon theparticular application and design constraints imposed on the overallsystem. Skilled artisans can implement the described functionality invarying ways for each particular application, but such implementationdecisions should not be interpreted as causing a departure from thescope of the present invention.

The various illustrative logical blocks, modules, and steps described inconnection with the embodiments disclosed herein can be implemented orperformed with a general purpose processor, a digital signal processor(DSP), an application specific integrated circuit (ASIC), a fieldprogrammable gate array (FPGA) or other programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof designed to perform the functions described herein.A general purpose processor can be a microprocessor, conventionalprocessor, controller, microcontroller, state machine, etc. A processorcan also be implemented as a combination of computing devices, e.g., acombination of a DSP and a microprocessor, a plurality ofmicroprocessors, one or more microprocessors in conjunction with a DSPcore, or any other such configuration. In addition, the term“processing” is a broad term meant to encompass several meaningsincluding, for example, implementing program code, executinginstructions, manipulating signals, filtering, performing arithmeticoperations, and the like.

The modules can include, but are not limited to, any of the following:software or hardware components such as software, object-orientedsoftware components, class components and task components, processes,methods, functions, attributes, procedures, subroutines, segments ofprogram code, drivers, firmware, microcode, circuitry, data, databases,data structures, tables, arrays, or variables.

The steps of a method or algorithm described in connection with theembodiments disclosed herein can be embodied directly in hardware, in asoftware module executed by a processor, or in a combination of the two.A software module can reside in RAM memory, flash memory, ROM memory,EPROM memory, EEPROM memory, registers, hard disk, a removable disk, aCD-ROM, a DVD, or any other form of storage medium known in the art. Astorage medium is coupled to the processor such that the processor canread information from, and write information to, the storage medium. Inthe alternative, the storage medium can be integral to the processor.The processor and the storage medium can reside in an ASIC. The ASIC canreside in a user terminal. In the alternative, the processor and thestorage medium can reside as discrete components in a user terminal.

Although the foregoing invention has been described in terms of certainpreferred embodiments, other embodiments will be apparent to those ofordinary skill in the art from the disclosure herein. Additionally,other combinations, omissions, substitutions and modifications will beapparent to the skilled artisan in view of the disclosure herein. It iscontemplated that various aspects and features of the inventiondescribed can be practiced separately, combined together, or substitutedfor one another, and that a variety of combinations and subcombinationsof the features and aspects can be made and still fall within the scopeof the invention. Furthermore, the systems described above need notinclude all of the modules and functions described in the preferredembodiments. Accordingly, the present invention is not intended to belimited by the reaction of the preferred embodiments, but is to bedefined by reference to the appended claims.

Additionally, all publications, patents, and patent applicationsmentioned in this specification are herein incorporated by reference tothe same extent as if each individual publication, patent, or patentapplication was specifically and individually indicated to beincorporated by reference.

What is claimed is:
 1. A method for processing physiologicalmeasurements, the method comprising: receiving, by a medical devicemanagement system, physiological measurement data from a portablemedical device, wherein the physiological measurement data comprisesidentification information associated with a user of the portablemedical device; identifying a user account of the medical devicemanagement system based on the identification information; processingthe physiological measurement data to determine at least onephysiological parameter associated with the physiological measurementdata; transmitting the determined at least one physiological parameterto the portable medical device for display; and storing thephysiological measurement data and the determined at least onephysiological parameter in the identified user account.
 2. The method ofclaim 1 further comprising providing the determined at least onephysiological parameter to a user account different from the identifieduser account based on one or more privacy settings of the identifieduser account.
 3. The method of claim 1, wherein the medical device is aglucometer.
 4. The method of claim 1, wherein the at least onephysiological parameter comprises glucose.
 5. The method of claim 1,wherein the physiological measurement data comprises non-invasivephysiological measurement data.
 6. The method of claim 1, wherein thephysiological measurement data comprises invasive physiological testdata.
 7. The method of claim 1, wherein the physiological measurementdata is contained in an XML file.
 8. A method for calibrating a portablemedical device, the method comprising: receive a request for calibrationfrom a portable medical device, wherein the request includesidentification information associated with the medical device; identifyan account associated with the medical device based on theidentification information; determining that the device needscalibration based on the information stored in the account; sending asignal to the medical device to initiate a calibration mode on themedical device; receiving calibration data from the medical device;processing the calibration data to determine a calibration of the devicetransmitting an updated calibration to medical device; and storing theupdated calibration in the account associated with the medical device.9. The method of claim 8, wherein the calibration is based on historicalinformation associated with the user account.
 10. The method of claim 8,wherein the medical device is a glucometer.
 11. The method of claim 8,wherein the calibration can be a single point calibration.
 12. Themethod of claim 8, wherein calibration data comprises non-invasivephysiological data.
 13. The method of claim 8, wherein calibration datacomprises invasive physiological data.
 14. The method of claim 8,wherein calibration is patient specific.
 15. A medical device managementsystem comprising: a data store configured to store user accountinformation associated with a plurality of user accounts; and acomputing device in communication with the data store, the computingdevice configured to: receive a measurement request from a portablemedical device, wherein the measurement request comprises physiologicalmeasurement data; identify a user account of the plurality of useraccounts associated with the measurement request; process thephysiological measurement data to determine at least one physiologicalparameter associated with the physiological measurement data; transmitthe determined at least one physiological parameter to the portablemedical device for display; and storing the physiological measurementdata and the determined at least one physiological parameter in theidentified user account.
 16. The system of claim 15, wherein the datastore is further configured to store user specific calibration dataassociated with the device.
 17. The system of claim 15, wherein the atleast one physiological parameter is a least one of invasive glucosetesting, non-invasive blood glucose testing, Oxygen Saturation (SpO2),Total Hemoglobin (SpHb), Alkaline Phosphatase (SpALP), Total Cholesterol(SpChol), High-Density Lipoprotein (SpHDL), or Total Cholesterol Dividedby High Density Lipoprotein (SpChol/SpHDL).
 18. The system of claim 15,wherein the user account stores a log of all measurements andcalibrations associated with each user account.
 19. The system of claim15, wherein the data store is further configured to store device profileinformation associated with a plurality of device profiles and thecomputing device is further configured to identify a device profile ofthe plurality of device profiles based on identification information.20. The system of claim 19, wherein multiple users are associated withthe same device profile.